Hospira, Inc.
Form 483 issued June 17, 2011 · Rocky Mount, North Carolina
- Inspection
- May 16 – Jun 17, 2011
- Investigators
- Claudette D. Brooks· Jason F. Chancey· Penny H. McCarver
- Observations
- 18
- Pages
- 14
- FEI number
- 1021343
In short: On June 17, 2011, FDA issued a Form 483 with 18 observations to Hospira, Inc. in Rocky Mount, North Carolina (FEI 1021343) after an inspection that ran May 16 – Jun 17, 2011. The investigators were Claudette D. Brooks, Jason F. Chancey and Penny H. McCarver. Most observations concern quality system and facilities & equipment; the most-cited regulation is 21 CFR 211.192 (production record review).
At a glance
Observations span 4 systems, led by quality system.
Most cited: 21 CFR 211.192 (3×) · 820.75(a) (2×)
What FDA observed
Preview: the opening words of each observation- 01
There is no written testing program designed to assess the stability…
- 02
The responsibilities and procedures applicable to the quality control unit…
- 03
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch…
- 04
Written records of investigations into unexplained discrepancies and the failure of a batch or any of…
This inspection in context
Claudette D. Brooks
6 documents · 2003–2018
Cites 820.70 (production and process controls) more than any other section. Most of their documents are for sites in North Carolina.
The firmHospira, Inc. history
All 9 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.192
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Hospira, Inc.?
FDA listed 18 observations on this Form 483, mostly about quality system, facilities & equipment and laboratory controls. The most-cited regulation is 21 CFR 211.192 (production record review). The opening words of each observation are shown on this page.
Who inspected Hospira, Inc.?
Claudette D. Brooks, Jason F. Chancey and Penny H. McCarver are named on this Form 483, for the inspection of May 16 – Jun 17, 2011. Each investigator has a profile showing what they cite most.
When was Hospira, Inc. inspected by FDA?
The inspection ran May 16 – Jun 17, 2011, and the Form 483 is dated June 17, 2011.
How do I get the full Form 483 for Hospira, Inc.?
Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.